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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K912596
Device Name MECONIUM ASPIRATION
Applicant
PACIFIC DEVICE, INC.
8572 SPECTRUM LN.
SAN DIEGO,  CA  92121
Applicant Contact JIM CAPUTO
Correspondent
PACIFIC DEVICE, INC.
8572 SPECTRUM LN.
SAN DIEGO,  CA  92121
Correspondent Contact JIM CAPUTO
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/10/1991
Decision Date 07/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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